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Back pain is a problem that is prevalent in the modern world. In the United States of America alone, there is an expected 31 million people with lower back pain at any given time. more facts |
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| SR 500 : Clinical Trial Study Results | |
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These studies have been carried out at the Department of Orthopaedic Surgery, College of Medicine, Inje University Seoul Paik Hospital. The studies were performed by Professor Byungjik Kim, Professor Shinwoo Park and their teams. |
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This study into the performance of the efficacy of the SR 500 after use by patients with low back pain, has evaluated pain levels, radiographic changes and strength of both flexor and extensor muscles at the lumbar vertebrae by using an isokinetic evaluation device.
II. The Subject and Methods of study
1. Patient Profile: 22 patients with acute or chronic lumbago; age ranging from 19 to 58 with average age of 44, 8 patients in the age range of 50 to 59 years, 9 men and 13 women, 9 patients with herniated disc, 9 patients with acute lumbago and 4 patients with chronic lumbago. |
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| Table 1. Age & Sex distribution | |
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2. Method of the Study
Firstly, Macnab’s criteria was used to examine changes of the pain. Secondly, radiographic imaging was used to analyze side views of the lumbar and sacral vertebrae, comparing with those Trunk Extension Flexion (TEF) Unit was used to measure and analyze muscular strength of the flexor and the extensor at the lumbar vertegrae. |
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| III. Results of the study | |
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1. Changes in Pain Status
Macnab’s criteria were measured as follows: “Excellent” is a state without pain, without restriction of movement and which would allow the subject to work normally. “Good” is a state with occasional pain, but which would allow the subject to work normally. “Fair” indicates slight progress, and “Poor” reflects no progress. The results in Table 2. show that approximately 85% reported favorable results with 3 subjects reporting “Excellent” relief of pain and 15 subjects reporting “Good” relief of pain (our of 22 subjects).
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Table 2. Pain relief before and after application of Air corset (SR 500)
2. Radiographic Changes
Results, from comparing X-rays of side views of the lumbar and sacral vertebrae before and after the application of the SR 500 in 12 cases, showed that the anterior curvature of the lumbar vertebrae had increased and the inter-vertebral disc interval at the 4th and 5th segment of the lumbar vertebrae had broadened by an average of 3mm.
3. Isokinetic Evaluation
Out of the 12 cases, 3 were randomly selected for evaluation using the Cybex 6000 - Trunk Extension Flex (TEF) Unit. According to the results from comparing the total joule at 60 angular velocity, peak torque, the ratio of peak torque to weight and average muscle power measured before and after the application of the SR 300. The following graphs demonstrate that the extensor muscle power was sustained longer after the use of the SR 500. Therefore, we decided that the SR 500 was useful in reinforcing muscular strength. From the results obtained, the increased anterior lumbar curve, as shown radio graphically, can be said to be caused not only by physical distraction, but also by increased muscle strength.
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| It was shown that approximately 85% of the subjects reported either “Excellent” or “Good” results after 3 days of using the SR 500 (3 Excellent, 15 Good out of a total of 22 subjects). In the radiographic test and isokinetic evaluation, the increase in the anterior curvature of the lumbar vertebrae and the increased distraction between the fourth and fifth lumbar vertebrae were found. Also, the mobility of extensor muscles were improved. These results were obtained from both the subjective and objective examination of the subjects and lead us to believe that use of SR 500 can play an important and effective role in the treatment of both acute & chronic low back pain patients. |
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| V. Efficacy and Effect of the SR 500 | |
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The SR 500 is judged to have effects on both acute and chronic low back pain caused by the following factors:
- Acute & Chronic Sprain of Lumbar Vertebrae
- Lumbar Facet Syndrome
- Herniated Intervertebral Disc
- Bulging Disc
- Spondylolisthesis
- Spinal Stenosis
- Spondylosis
- Degenerative Disc Disease
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